Efficacy of Dolasetron in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

— Dolastron  

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Study of Efficacy of DOLASETRON in Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820326
• Other study ID #: I03002
• Status: Completed
• Phase: Phase 3
• First received: December 27, 2008
• Last updated: January 9, 2009
• Start date: March 2004
• Est. completion date: June 2008

Study information

• Verified date: January 2009
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

This study offers a new treatment, dolasetron or ANZEMET ®, which will be administered by intravenous way once a day during a 4 days Hospitalization.

This study is double blind (neither you nor the physician will know if you are receiving active study drug or placebo).

Randomisation at the beginning of the study will decide whether you receive active treatment or its placebo.

This treatment will be renewed after one month, after 2 months and after 3 months.

If the study staff determines that you are eligible and you decide to participate, there will be approximately 6 study visits in about 9 months. During these visits, you will undergo routine health exams and complete different kinds of questionnaires.

Following this first period of 3 months, you agree to come back for consultation at month 4, month 6 and month 12 for monitoring and evaluating the effects of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients aged 18 to 75

• Primitive Fibromyalgia according to ACR criteria

• Patient no responding to conventional treatment

• Women of childbearing age using an efficace contraception

• Signed consent

Exclusion Criteria:

• Inflammatory rheumatic diseases

• Diseases of the system: Gougerot Sjögren, polymyositis, vasculitis,

• Infectious diseases: hepatitis B and C, lyme disease, HIV,

• Hypothyroidism,

• Bone and mineral metabolism disorders

• Disorders of cardiac conduction

• Failure of Heart, of kidney or liver,

• Patient allergic to dolasetron

• Pregnant or nursing women

• Women without means of contraception,

• Age <18 or > 75 years.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Dolasetron
Patients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3
• Placebo
Patients will receive placebo everyday for 4 days at J0, M1, M2 and M3

Locations

Country	Name	City	State
France	Service de Rhumatologie, CHu de Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: Improving visual analogue scale (VAS) between Inclusion visit and month 3		Inclusion visit and month 3	Yes
Secondary	Improving visual analogue scale (VAS)		Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.	Yes
Secondary	Fibromyalgia impact questionnaire SF-36 scale and Beck depression scale		Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.	Yes
Secondary	Anxiety index		Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.	Yes
Secondary	Number of painful trigger points		Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.	Yes